Abstract
Aim: To evaluate if intensive insulin regimen with multiple daily injections (MDI) is successful for treating type 1 diabetes patients over a long period of time in a regular clinical setting.
Method: This is a prospective, observational seven-year study. Fifty-nine (35male) type 1 diabetic patients with bad metabolic control (HbA1c≥9%), aged 31.9 years, range 18-47 were included in the present study. All of them had had at least 5 years of diabetes duration after diagnosis and showed negative responses of serum C-peptide to a standard breakfast. The main control variables are: Metabolic control measured by serum HbA1c values (values < 6.2 % was the treatment objective) and the frequency of hypoglycaemic episodes (episodes/patient-month).
Results: Significant decreases in mean±SD HbA1c values in this group of patients were observed from the first year of follow-up, with the mean values being: 7.5±1.5%, 7.2±1.8%, 7.6±1.6%, 7.1±1.7%, 7±1.4, 6.6±1.6% and 6.8±1.4% for the first, second, third, fourth, fifth, sixth and seventh years of follow-up respectively. Sixteen %, 27.5%, 15.7%, 33.3%, 28.6%, 42% and 33% of the patients reached the treatment objective (HbA1c values<6.2%) for each year of follow-up. Throughout the study period the rate of severe hypoglycaemia (episodes/patient-year) was 0.32±0.2 which was not significantly different compared with the value of 0.28±0.1 observed the year before the study began. Similarly frequencies of mild/moderate hypoglycaemia episodes (episodes/patient-month) varies between 16.5±4 and 21.7±5, which are not significantly different from the value of 17.7±6 observed the year before the study began.
Conclusion: Long-term improvement in metabolic control was observed in this group of type 1 diabetes patients with previous bad control, during treatment in a regular clinical setting. A considerable percentage of type 1 diabetic patients with MDI reached the treatment objective in every year of follow-up. Furthermore improvement in metabolic control is not associated with significantly increased frequency of hypoglycaemia episodes.
Key words
type 1 diabetes - intensive insulin regimen - HbA1c - hypoglycaemia
References
1
American Diabetes Association (ADA) .
Standards of Medical Care for patients with diabetes mellitus.
Diabetes care.
1996;
19(Suppl. 1)
S8-S15
2
American Diabetes Association (ADA) .
Standards of medical care for patients with diabetes mellitus.
Diabetes Care.
2001;
24
S33-S43
3
Bott S, Bott U, Berger M, Mühlhauser I.
Intensified insulin therapy and the risk of severe hypoglycaemia.
Diabetologia.
1997;
40
926-932
4
DAFNE Study Group .
Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial.
BMJ.
2002;
325
746-751
5
DCCT research Group .
Weight associated with intensive therapy in the diabetes control and complications trial.
Diabetes Care.
1988;
11
567-570
6
DCCT Research Group .
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.
N Eng J Med.
1993;
329
977-986
7
DCCT group .
Hypoglycemia in the diabetes control and complications trial.
Diabetes.
1997;
46
271-274
8
DCCT Effect of intensive therapy on residual beta-cell functions in patients with type 1 diabetes in the Diabetes Control and Complications Trial. A randomised, controlled trial.
Ann Intern Med.
1998;
128
517-523
9
Epidemiology of Diabetes Interventions Research Group .
Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy.
N Eng J Med.
2000;
342
381-389
10
Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Taubert JP.
Comparison of continuous subcutaneous insulin infusion and multiple daily injections regimens using lispro in type 1 diabetic patients on intensified treatment.
Diabetes Care.
2000;
23
1232-1235
11
Lalli C, Ciofetta M, Del Sindaco P. et al .
Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime.
Diabetes Care.
1999;
22
468-477
12
Lepore G, Bruttomesso D, Nosari I, Tiengo A, Trevisan R.
Glycaemic control and microvascular complications in a large cohort of Italian type 1 out-patients.
Diab Nutr Metab.
2002;
15
232-239
13
Lepore G, Dodesine A, Nosari I, Trevisan R.
Both continuous subcutaneous insulin infusion and a multiple daily insulin injection regimen with glargine as basal insulin are equally better than traditional multiple daily insulin injection treatment.
Diabetes Care.
2003;
26
1321-1322
14
Mühlhauser I, Jörgens V, Berged M. et al .
Bicentric evaluation of a taching and treatment programme for type I (insulin-dependent) diabetic patients: improved of metabolic control and other measures of diabetes care for up to 22 months.
Diabetologia.
1983;
25
470-476
15
Plank J, Köhler G, Rakovac I. et al .
Long-term evaluation of a structured outpatient education programme for intensified insulin therapy in patients with type 1 diabetes: a 12-year follow-up.
Diabetologia.
2004;
47
1370-1375
16
Purnell JQ, Hokanson JE, Marcovina SM, Steffes MW, Cleary PA, Brunzell JD.
Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid and blood pressure. Results from the DCCT.
JAMA.
1998;
280
140-146
17
Reichard P, Nilsson BY, Rosenqvist U.
The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus.
N Eng J Med.
1993;
329
304-309
18
Tsui EYL, Chiasson LL, Tildesley H. et al .
Counterregulatory hormone response after long-term continuous subcutaneous insulin infusion with lispro insulin.
Diabetes Care.
1998;
21
93-96
19
Wang PH, Lau J, Chalmers TC.
Meta-analysis of effect of intensive blood glucose control on late complications of type 1 diabetes.
Lancet.
1993;
341
1306-1309
Correspondence
R. V. García-Mayor
P.O. Box 1691
36201 Vigo
Spain
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